RATIONALE: SU5416 may stop the growth of prostate cancer by stopping blood flow to the tumor. Dexamethasone may be effective in slowing the growth of prostate cancer cells. It is not yet known whether SU5416 or dexamethasone is more effective in treating progressive prostate cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of SU5416 with that of dexamethasone in treating patients who have progressive prostate cancer that has not responded to hormone therapy.

Detailed Description

OBJECTIVES:

Compare the time to progression in patients with hormone refractory prostate cancer treated with dexamethasone with or without SU5416.

Determine the differences in PSA kinetics and PSA hazard score between these two regimens in this patient population.

Determine the objective response rate and time to development of new lesions in these patients treated with SU5416.

Determine the toxicity of SU5416 in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive oral dexamethasone once a day 6 days a week. Treatment continues until disease progression, at which time patients cross over to arm II.

Arm II: Patients receive oral dexamethasone as in arm I followed by SU5416 IV over 60 minutes twice weekly for 4 weeks. A smaller dose of dexamethasone is administered the day after SU5416. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 16 months.

dexamethasone followed by SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment if tumor grows.

Interventions:

Drug: dexamethasone

Drug: semaxanib

Experimental: Arm A

SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment

Intervention: Drug: semaxanib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Histologically confirmed prostate cancer not amenable to curative treatment with surgery or radiotherapy

Progressive disease defined by 1 of the following criteria:

New bone scan lesions

New or progressive radiologic lesions

Sequential increases in PSA on at least 2 successive measurements no less than 2 weeks apart of at least 50% above nadir on prior therapy provided absolute value at time of enrollment is at least 5 ng/mL

Progressive disease, as defined above, despite adequate hormonal therapy defined by all of the following:

Continued treatment with an LHRH agonist or prior orchiectomy

Sequential or concurrent treatment with an antiandrogen (e.g., flutamide, nilutamide, or bicalutamide)

Trial of antiandrogen withdrawal at least 4 weeks prior to study

CNS metastasis allowed if:

Previously treated

Neurologically stable

Oral or intravenous steroids or anticonvulsants not required

Brain scan (CT or MRI) within the past 2 weeks shows no active or residual disease